Clinical Study Operations Specialist — Hybrid

Regeneron Pharmaceuticals; Warren (MI); On-site; USD 94,000 - 153,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Clinical Study Specialist to support trial teams from site activation through close-out, with on-site work and hybrid flexibility in Armonk, NY or Warren, NJ.

The role emphasizes analyzing reports, coordinating team meetings, data collection for site feasibility, and ensuring timely TMF and regulatory activities while maintaining strong site relationships.

Qualifications

• Bachelor’s degree with 2+ years of industry-related work experience in a clinical setting.
• Ability to acquire working knowledge in trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF)
• Basic familiarity with medical terms and clinical drug development
• Awareness of ICH/GCP
• Proactive, self-disciplined, and effective at managing deadlines and priorities

Responsibilities

• Organizes and delivers analyzable reports and metrics, and coordinates study team meetings, agendas, and minutes
• Collates data for feasibility and site selection assessments, and contributes to review of study documents (e.g., informed consent forms, case report forms) and reference materials (e.g., regulatory, pharmacy, laboratory binders)
• Tracks site activation, enrollment, and monitoring visits against projected plans, escalating issues or delays, and monitors investigator/site status and registry postings
• Ensures timely receipt of scheduled reports (e.g., 1572s, financial disclosures) and performs TMF reconciliations with study lead guidance
• Communicates with sites as directed, maintaining site contact information and strong relationships internally and externally
• Contributes to close-out activities (e.g., 1572s, IP reconciliation, financial disclosures, CRA close-out visits) and supports oversight of third-party vendors as needed
• Brings attention to detail, resourcefulness, and proactive problem-solving to assigned study activities, investigating impact on trials as new information arises
• Participates in SOP revisions and departmental initiatives, proactively recommending process improvements

Skills

Clinical trial experience

MS Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Education

Bachelor’s degree

Tools

MS Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Job description

Regeneron Pharmaceuticals is seeking a Clinical Study Specialist to support trial teams from site activation through close-out, with on-site work and hybrid flexibility in Armonk, NY or Warren, NJ.

The role emphasizes analyzing reports, coordinating team meetings, data collection for site feasibility, and ensuring timely TMF and regulatory activities while maintaining strong site relationships.